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OncoMatch/Clinical Trials/NCT06762782

Clinical Study on the Effectiveness and Safety of Lenvatinib As Adjuvant Treatment for Patients with High-risk Recurrence of Hepatocellular Carcinoma After Surgery

Is NCT06762782 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Postoperative adjuvant lenvatinib for hepatocellular carcinoma (hcc).

Phase 2RecruitingThe First Affiliated Hospital with Nanjing Medical UniversityNCT06762782Data as of May 2026

Treatment: Postoperative adjuvant lenvatinibThis study is a prospective, randomized, controlled, open, phase II, multicenter clinical study, which aims to evaluate the efficacy and safety of lenvatinib for adjuvant treatment of high-risk recurrent liver cancer after radical surgery. This study is divided into 3 stages: screening period (screening period 28 days), treatment period (up to 12 months, or until any of the following occurs, whichever occurs first: ① The subject has an intolerable toxic reaction and is still not relieved after dose adjustment; ② The subject's first imaging confirmed disease recurrence or withdrew from the study for other reasons), and follow-up period (12 months after the end of treatment). Dosage regimen: Eligible subjects were randomly assigned to the experimental group or the control group in a 2:1 ratio, with surgical method (radical surgery vs ablation) as the stratification factor. The experimental group received lenvatinib treatment, and the control group received best supportive care

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Disease stage

Grade: edmondson iiiedmondson iv (edmondson)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

No prior treatment (treatment-naive required)

Must have received: curative surgery or ablation — adjuvant

Received radical treatment surgery for liver cancer within 4 to 8 weeks prior to enrollment

Cannot have received: targeted drug therapy (sorafenib, lenvatinib, regorafenib)

Received targeted drug therapy such as sorafenib, lenvatinib, regorafenib, or immunomodulatory therapy such as anti-PD-1, anti-PD-L1, anti-CTLA-4 before surgery

Cannot have received: immunomodulatory therapy (anti-PD-1, anti-PD-L1, anti-CTLA-4)

Received targeted drug therapy such as sorafenib, lenvatinib, regorafenib, or immunomodulatory therapy such as anti-PD-1, anti-PD-L1, anti-CTLA-4 before surgery

Cannot have received: antitumor treatment

no antitumor treatment before surgery

Cannot have received: reoperation for recurrent liver cancer

Reoperation for recurrent liver cancer

Lab requirements

Blood counts

hemoglobin ≥90 g/l; anc ≥1.5×10^9/l; platelet count ≥75×10^9/l

Kidney function

creatinine ≤1.5×uln

Liver function

albumin ≥28 g/l; total bilirubin ≤1.5×uln; ast, alt ≤3×uln

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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